Celcuity (CELC) announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. In the trial, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant. The mPFS, as assessed by blinded independent central review, was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on CELC:
- Celcuity doses first patient in VIKTORIA-2 trial
- Celcuity announces issuance of new patent for gedatolisib
- Promising Clinical Trial Results and Favorable Safety Profile Drive Buy Rating for Celcuity’s Gedatolisib
- Celcuity resumed with a Buy at Stifel
- Promising Preliminary Data and Positive Outlook for Celcuity’s Gedatolisib in Cancer Trials